Transition Oral Appliances Are Bridging the Gap

There is no doubt that sleep apnea patients are looking for options above and beyond CPAP therapy. Custom oral appliances are making inroads, but cost is still a major hurdle.

The solution is a new middle ground of “transition” oral appliances designed to help treat and determine who may be responders—or non-responders—for more expensive custom oral appliance therapy. The American Academy of Sleep Medicine annual meeting unveiled several products along these lines, including ApneaRx® from Apnea Sciences Corporation.

ApneaRx, an easy-to-use boil-and-bite device, varies from its competitors in that it can be fitted and titrated by trained sleep care specialists—not just dentists. Patrick Wolcott, MD a sleep specialist with offices in Encinitas and El Centro, Calif, was one of the 1st sleep specialists to use ApneaRx, and he has seen its benefits first hand. According to Dr Wolcott, “Many sleep apnea suffers avoid treatment because they think the only option is wearing a CPAP mask to bed. By offering more treatment options, the patient’s anxiety about treating their sleep apnea is reduced.”

Wolcott is a firm believer in the CPAP gold standard, but he also realizes that many patients would like to be aware of, and have the opportunity to choose, other treatment modalities. The option of a boil-and-bite oral appliance, such as ApneaRx, allows for fitting in less than 15 minutes, and can be adjusted and calibrated by patients in 1 mm increments—without the need for screws, plastic bands, or other accessories.

The device is also affordable, and it is a good alternative for frequent travelers who do not take CPAP with them, or for patients without health insurance. Wolcott offers ApneaRx for mild to moderate sleep apnea, and to non-compliant CPAP patients who refuse to use CPAP.

Dr Wolcott’s office staff fits the device in the office and instructs the patient to wear it at a modest advancement (1 to 2 mm) for about 3 days to get used to it. “The patient then advances the ApneaRx in 1 mm increments based on their comfort level and reduced symptoms like snoring or tiredness,” says Wolcott. “After 2 weeks, the patient is scheduled for a follow up clinic visit.” A sleep study is performed when the device is felt to be in optimal position.

Once a level of comfort is reached, treatment options for patients are expanded to include: moving forward with custom oral appliance therapy; trying or going back to CPAP; exploring surgical options; or continuing to use ApneaRx. Wolcott reiterates that “By involving the patients in choosing their treatment, they seem more willing and committed to managing their sleep apnea no matter what the therapy. The end result is more patients get treated and are compliant.”

Affordability is Key

Custom oral appliances can be highly effective, but they are expensive. Patients generally do not want to pay if they can’t be sure the device will be right for them. ApneaRx’s micro-adjustable boil-and-bite sleep apnea appliance is a prescription device, but it is an affordable way to help sleep care practitioners determine who will be good candidates for more expensive custom oral appliance therapy.

“Patients can trial these at a relatively low cost—and ApneaRx fits this bill,” adds Wolcott. “You can find out if oral appliances are something patients are comfortable using. Can they sleep well with it? Or are they uncomfortable with a device in their mouth all night?”

Oral appliances do not work 100% of the time, and trying to predict which patients will succeed is an inexact science. “Even in patients with mild to moderate sleep apnea, we sometimes don’t see a significant improvement,” says Dr Wolcott. “If it works, then you can transition patients to a custom device—which will last 3 to 5 years. In this scenario, the extra cost of the custom device is worth the investment and/or the out of pocket cost the patient faces.”

According to sleep physician Frank Barch, Harrisonburg, Va, who has sleep apnea and uses ApneaRx, “I have been looking for an oral appliance like ApneaRx for some time. Sleep MDs now have an easily titratable device that can be used to help predict the clinical utility of more expensive custom oral appliance therapy.”

Barch adds that ApneaRx can also be offered to select sleep apnea patients who have no (or limited) health insurance as an affordable transition therapy. For appropriate patients who use PAP therapy, ApneaRx can offer a cost effective alternative when they are unable to use their PAP therapy, such as on camping trips.

ApneaRx is distributed by CareFusion, and according to Randy Clare, CareFusion’s sleep business leader, “Sleep practitioners have quickly recognized ApneaRx’s potential as a diagnostic tool to help determine who may be responders, or non-responders for more expensive custom oral appliance therapy. In addition, they view ApneaRx as an affordable and easy-to-use ‘transition’ treatment alternative for those sleep apnea patients who do not have health insurance.”  CareFusion can be contacted at or (800) 582-7458.

For more information about ApneaRx, visit or contact Patrick Maley, Apnea Sciences’ COO, at or via phone: (617) 835-3757.

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